A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines.

Jens D Lundgren, MD

Status and phase: Completed; Phase 4

Conditions: SARS CoV 2 Infection

Treatments: Biological: Johnson & Johnson

Study type: Interventional

Funder types: Other

Identifiers

NCT06360744

ENFORCE PLUS

Details and patient eligibility

About

A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson & Johnson/Janssen (J&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.

The Danish Medicines Agency has approved the vaccine from J&J for use in Denmark, however it is not currently part of the national vaccine programme.

The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).

Full description

Participants will have 3 specific study visits and will hereafter be followed for 2 years after the vaccination with regular visits after 3, 6, 12 and 24 month. In this way the participants will be offered an extra close follow up on vaccine effectiveness.

Safety data will be collected at study visits until 3 months after the first vaccination,, with additional safety data collected under this protocol during the first month after vaccination.

Research samples will be collected at each study visit during the two-year follow-up.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Written informed consent obtained before any trial related procedures are performed
2. Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the 'Tilvalgsordningen')
3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples)

Exclusion criteria

1. Male and female under the age of 18

2. Any subgroup of individuals for which the vaccine is contra-indicated

3. Previous SARS-CoV-2 vaccination

   Specific for the Johnson & Johnson vaccine:

4. Experience of a serious allergic reaction after injection of any other vaccine

5. Serious infection with high fever (> 38 0C) A temporary postponement of the vaccination is allowed, when participant has been well for at least 48 hours. Mild fever or upper airway infection like a cold is not a problem

6. Problems with bleeding or bruising, or use of anticoagulant medicine (to prevent blood clots)

7. Immunodeficiency or use of medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Vaccine Johnson and Johnson/Janssen Covid-19 vaccine

Other group

Description:

Johnson \& Johnson/Janssen Covid-19 vaccine.

Treatment:

Biological: Johnson & Johnson